复方冰甲乳膏的配方与制剂工艺研究

发布时间：2018-06-05 12:37

  本文选题：复方冰甲乳膏 + 甲硝唑　； 参考：《中国药房》2015年22期

【摘要】：目的:优选复方冰甲乳膏的基质配方和制剂工艺参数。方法:分别制备水相和油相基质溶液,将前者加入后者中混匀,通过外观性状和高温、低温、离心试验后油水分层的综合总分为评价指标,优选基质配方。采用高效液相色谱法测定甲硝唑含量、气相色谱法测定冰片含量;以加入主药混合物时基质的温度、基质用量、乳化方式和乳化时间为考察因素,以甲硝唑含量、冰片含量和制剂综合总分(制剂外观及稳定性评价得分之和)的综合评分为考察指标,设计L9(34)正交试验,优选复方冰甲乳膏的制剂工艺参数并进行工艺验证。结果:优选的油相基质配方为十六醇10 g、单硬脂酸甘油酯16 g、硬脂酸20 g、白凡士林8 g,水相基质配方为三乙醇胺2 g、甘油24 g;优选的制剂工艺参数为加入主药混合物时基质温度50℃、基质用量300 g、胶体乳化、乳化时间30 min,此工艺参数下甲硝唑含量为1.83%、冰片含量为2.88%;3次验证试验中,制剂综合总分均为25分,甲硝唑含量分别为2.1%、2.1%、2.2%(RSD为2.71%,n=3),冰片含量分别为3.2%、3.3%、3.1%(RSD为3.12%,n=3)。结论:优选的制剂基质配方和工艺参数稳定、可行,适合批量生产。
[Abstract]:Objective: to optimize the matrix formulation and preparation parameters of compound Bing A cream. Methods: water phase and oil phase matrix solution were prepared, and the former was mixed in the latter. The composite score of oil and water stratification after centrifugation was selected as evaluation index through appearance characteristics and high temperature and low temperature. The content of metronidazole was determined by HPLC, the content of borneol was determined by gas chromatography, and the content of metronidazole was determined by the temperature, dosage, emulsification mode and emulsification time of the matrix when the main drug mixture was added. The synthetic score of the content of borneol and the total score of the preparation (the sum of the evaluation score of the appearance and stability of the preparation) was used as the inspection index. The orthogonal test was designed to optimize the preparation parameters of compound Bing A cream and to verify the process. Results: the optimized oil matrix formula was hexadecanol 10 g, glycerol monostearate 16 g, stearic acid 20 g, white vaseline 8 g, water phase base formulation 2 g triethanolamine and glycerol 24 g. The substrate temperature is 50 鈩，

本文编号：1982014